FORMÜLASYON GELİŞTİRME VE CTD HAZIRLAMA

Product Development Services Formulation and preformulation

Pharmaceutical Product Development for all types of the conventional drug forms: Tablet, capsule, suspension, syrup, gel, pomade, cream, sterile vials and ampoules, inhaler etc. 
•Formulation of intermediates
•Optimization of existing formulations
•In-vitro dissolution studies
•Analytical Development and validation
•Consultancy in finding proper contract manufacturing facility 
•Analysis of active pharmaceutical ingredient and excipients in accordance with international pharmacopoeias

Regulatory Services

•Preparation of drug registration dossiers in CTD format according to the requirements of the Republic of Turkey Ministry of Health
•Converting drug registration dossiers from NTA format to CTD  format
•Follow-up and monitoring the registration period in related health authority, in accordance with the applicant’s demands
•Answering  Ministry questions
•All types of variation applications 
•Clinical and non-clinical study reports
•License renewal
•Regulatory Services for Dossier preparation for submission in the Turkey, Europe, US.